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Novartis Study Start-Up Clinical Research Associate (SSU CRA) job vacancy
India
Job Purpose:
Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Study Start-Up Manager, SSO Feasibility Manager as well as SSO Site Partnership Manager
• Collaborates with SSO Study Start-Up Manager, SSO Study Start-Up Team Lead and global study team to ensure Study Start-Up timelines and deliverables are met according to country commitments. Accountable for timely start-up activities from country allocation until site greenlight at assigned sites. Conducts site selection visits, verifies site eligibility for a specific study
• Main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation. Ensures that milestones (KPIs) and time schedule for study start-up are met as planned. Facilitates the preparation and collection of site and country level documents
• Collects submission relevant site-specific documents (e.g., FD, CV, GCP certificates, DSL…) for all relevant site personnel within agreed timelines. Supports SSU Manager in preparation of country-specific documents, e.g., ICF, patient facing materials, etc.
• Supports SSO Study Start-Up Manager and assigned sites in vendor set-up activities. Prepare and finalize site specific documents for submission. Negotiates investigator payments as needed
• Supports preparation of financial contracts between Novartis and investigational sites and investigators as needed. Updates all systems until site Green Light on an ongoing basis. Supports preparation of audits and inspections as applicable
• Supports reduction of formal site-specific IRB/IEC deficiencies. Ensures timelines, accuracy, and quality of country and site TMF documents in study start-up to
ensure TMF inspection readiness. Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health
Authority and SOP requirements
• Implements innovative and efficient processes which are in line with Novartis strategy. Ensures sites are prepared for “Green Light” and is accountable to send the Green Light to SSU. Manager for review and approval.
Role Requirements
Education: • A degree in scientific or health discipline, preferably with
clinical operations experience (or, for United States: 4-year
degree plus relevant, related healthcare experience)
Languages: • Fluent in both written and spoken English, local language
as needed
Experience/Professional
requirement:
• Minimum 3 years’ experience in clinical operations in a
monitoring / site management role
• Advanced understanding of all aspects of clinical drug
development with particular emphasis on trial set-up,
execution, and monitoring
• Central/in-house monitoring or field monitoring experience is
desirable
Division:
Development
Business Unit:
GCO GDD
Work Location:
Mumbai
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